A multicenter, randomized, open and positive parallel controlled clinical study of clotrimazole vaginal expansion suppository and vaginal tablet in the treatment of mild and moderate vulvovaginal candidiasis
Zhang Lei, Liao Qinping, Wang Chaohua, Zhang Dai, An Ruifang, Zheng Jianhua, Wang Ying, Zhang Qiongqiong, Chen Rui
Published 2020-10-25
Cite as Chin J Obstet Gynecol, 2020, 55(10): 697-702. DOI: 10.3760/cma.j.cn112141-20200403-00293
Abstract
ObjectiveUsing clotrimazole vaginal tablet as a positive control, to evaluate the results of clotrimazole vaginal expansion suppository in the treatment of mild and moderate vulvovaginal candidiasis in terms of efficacy, patient satisfaction, side effects, and recurrence rate.
MethodsThis study was jointly conducted by 5 hospitals from August 2017 to October 2018, patients with mild and moderate vulvovaginal candidiasis confirmed by fungal culture and symptoms scores were selected. They were randomized to experimental group and control group as 1∶1 ratio. In the experimental group (n=105), the subjects applied clotrimazole vaginal expansion suppository (150 mg) daily at night for 7 days. In the control group (n=106), the subjects used a single dose of clotrimazole vaginal tablet (500 mg). Follow-ups were performed at (8±3) and (30±5) days after the discontinuation of the drugs, respectively. The difference in clinical symptoms and signs scores was used to evaluate the improvement of clinical symptoms, and the patient′s satisfaction and side effects were recorded.
ResultsAt the first follow-up, the experimental group and control group were followed up by fungal culture on the cure rate [66.7% (70/105) versus 63.2% (67/106), P>0.05] and total effective rate [98.1% (103/105) versus 99.1% (105/106),P>0.05], the differences were not statistically significant. At the second follow-up, the recurrence rates of the experimental group and the control group were 5.7% (4/70) and 14.9% (10/67), respectively, with no significant difference (P>0.05). In the evaluation of patient satisfaction, the leakage of the drug in the experimental group was significantly better than that in the control group (P<0.01). The side effects mainly included vaginal stimulation, itching and burning sensation, and there was no statistical difference between the two groups (χ2=1.070, P=0.586).
ConclusionsIn the treatment of mild and moderate vulvovaginal candidiasis, clotrimazole vaginal expansion suppository is no less effective than clotrimazole vaginal tablet, and there is no significant difference in the recurrence rate between the two. In terms of patient satisfaction, clotrimazole vaginal expansion suppository is superior to clotrimazole vaginal tablet.
Key words:
Clotrimazole; Administration, intravaginal; Suppositories; Tablets; Multicenter study; Controlled clinical trial; Vulvovaginal candidiasis
Contributor Information
Zhang Lei
Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China
Liao Qinping
Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China
Wang Chaohua
Department of Obstetrics and Gynecology, Peking University People′s Hospital, Beijing 100044, China
Zhang Dai
Department of Obstetrics and Gynecology, Peking University First hospital, Beijing 100034, China
An Ruifang
Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xi′an Jiaotong University, Xi′an 710061, China
Zheng Jianhua
Department of Obstetrics and Gynecology, The First Affiliated Hospital of Harbin Medical University, Harbin 150001, China
Wang Ying
Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China
Zhang Qiongqiong
Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China
Chen Rui
Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China
